JP2005177498A - Infusion port for infusing fluid into body, and method for arranging infusion port - Google Patents

Infusion port for infusing fluid into body, and method for arranging infusion port Download PDF

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JP2005177498A
JP2005177498A JP2004366378A JP2004366378A JP2005177498A JP 2005177498 A JP2005177498 A JP 2005177498A JP 2004366378 A JP2004366378 A JP 2004366378A JP 2004366378 A JP2004366378 A JP 2004366378A JP 2005177498 A JP2005177498 A JP 2005177498A
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housing
injection port
fastener
tissue
flange
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JP4828119B2 (en
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Sean P Conlon
ショーン・ピー・コンロン
Ronald John Kolata
ロナルド・ジョン・コラタ
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Ethicon Endo Surgery Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0208—Subcutaneous access sites for injecting or removing fluids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0208—Subcutaneous access sites for injecting or removing fluids
    • A61M2039/0223—Subcutaneous access sites for injecting or removing fluids having means for anchoring the subcutaneous access site

Abstract

<P>PROBLEM TO BE SOLVED: To provide a fluid infusion port which is held over a long period of time while being able to be quickly attached, and is suitable for subcutaneous attachment. <P>SOLUTION: This automatic attaching type infusion port has an integral fastener which is fixed to a housing and extends from the housing. As the fastener, a one-directional fastener which is formed of a plurality of annular flanges having a truncated cone shape being arranged with an interval in the axial direction and being concentrically arranged, or the like. The infusion port is automatically attached when a surgeon applies a force facing the distal to the housing of the infusion port, and the fastener penetrates the tissue and engages with the tissue to hold the infusion port at a specified position. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

関連出願
本出願の主張する優先権の基礎となる米国特許出願は、その開示内容が本明細書で参照文献として引用される２００３年６月１６日に出願された米国仮特許出願第６０／４７８，７６３号「調節可能な胃バンド用の流体注入ポート（Fluid Injection Port For Adjustable Gastric Band）」に基づく優先権を主張している。本明細書では、本出願の主張する優先権の基礎となる米国特許出願と同日に出願された以下の同時係属中の特許出願、すなわち、米国特許出願第１０／７４１，１２７号（「適用された締結具用の皮下注入ポート（Subcutaneous Injection Port For Applied Fasteners）」、発明者：コンロン（Conlon）およびハント（Hunt））、および米国特許出願第１０／７４１，７８５号（「一体的な可動式の保持部材を備えた皮下自動取り付け式注入ポート（Subcutaneous Self Attaching Injection Port With Integral Moveable Retention Members）」、発明者：コンロン、バイラム（Byrum）、ハント、ニューコルス（Nuchols）、およびシュルツェ（Schulze））をも参照文献として引用する。 RELATED APPLICATIONS US patent applications that are the basis of the priority claimed in this application are US Provisional Patent Application No. 60/478, filed Jun. 16, 2003, the disclosure of which is incorporated herein by reference. , 763 "Fluid Injection Port For Adjustable Gastric Band". As used herein, the following co-pending patent application filed on the same day as the US patent application on which the priority of the present application is claimed: US patent application Ser. No. 10 / 741,127 (“ Subcutaneous Injection Port For Applied Fasteners ", Inventors: Conlon and Hunt, and U.S. Patent Application No. 10 / 741,785 (" Integrally Movable " Subcutaneous Self Attaching Injection Port With Integral Moveable Retention Members ", Inventors: Konlon, Byrum, Hunt, Nuchols, and Schulze) Is also cited as a reference.

本発明は、大まかに言って外科的に植込み可能な流体注入ポートに関し、より詳しく言うと皮下で取り付けられたポートの周縁を締結するための締結具および方法に関する。本発明は調節可能な胃バンドに用いられる注入ポートに関して具体的に記載されるが、本発明の締結具は、薬剤の注入および血液の吸引のような血管にアクセスするために用いられる注入ポートを含めたさまざまな皮下に取り付けられた器具に用いられてよい。   The present invention relates generally to a surgically implantable fluid injection port, and more particularly to a fastener and method for fastening the periphery of a subcutaneously attached port. Although the present invention is specifically described with respect to an infusion port used for an adjustable gastric band, the fastener of the present invention provides an infusion port used to access blood vessels such as drug infusion and blood aspiration. It may be used with a variety of subcutaneously attached devices, including:

注入ポートは、薬剤の注入および血液の吸引のためなどの体内に流体を注入するため、および調節可能な胃バンドを含めたその他のさまざまな用途のために体の皮膚の下に配置される。１９８０年代の初め以来、調節可能な胃バンドが病的な肥満のための胃バイパス手術およびその他の不可逆性の外科的な減量治療に代わる有効な代替物となってきた。胃バンドは患者の胃の上部の周りに巻き付けられて、胃の上部から下部へ食物が通過するのを制限する小孔（stoma）を形成している。小孔が適切な寸法の場合、胃の上部に収容された食物は過食を抑制する満腹感をもたらす。しかし、初期の適応障害または胃の経時的な変化によって、胃バンドの調節を必要とするように小孔の寸法が不適切になることがある。調節が行われないと、患者は小孔が適切に食物を通過させるには小さすぎる場合に嘔吐の発作および不快感を経験することもある。もう一方の極端な場合には、小孔が大きすぎて胃の上部からの食物の移動を遅らせることができず、胃バンドの目的がまったく達せられなくなる。   The infusion port is placed under the skin of the body for injecting fluids into the body, such as for drug infusion and blood aspiration, and for various other uses, including adjustable gastric bands. Since the early 1980s, adjustable gastric bands have become an effective alternative to gastric bypass surgery and other irreversible surgical weight loss treatments for morbid obesity. The gastric band is wrapped around the upper part of the patient's stomach to form a stoma that restricts the passage of food from the upper part of the stomach to the lower part. If the stoma is of an appropriate size, food contained in the upper stomach provides a feeling of satiety that suppresses overeating. However, early adaptation disturbances or changes in the stomach over time can result in an inappropriate pore size that requires adjustment of the gastric band. Without adjustment, patients may experience vomiting attacks and discomfort if the stoma is too small to properly pass food. In the other extreme case, the stoma is too large to delay the movement of food from the upper part of the stomach, and the purpose of the gastric band cannot be achieved at all.

胃バンドの外径を設定するための締結位置に加えて、胃バンドは食塩水などの流体が流体注入ポートを通して注入されて所望の直径を達成するバルーン血圧カフに類似した内向きに膨張可能なバルーンによって調節可能にされている。調節可能なバルーンは長期間に亘って患者の体内に留置されることもあるので、流体注入ポートは汚染を防止するために典型的には皮下に、例えば胸骨の前に植込まれる。調節可能な胃バンド内の流体の量は注入ポートのシリコーン内に皮膚を通してヒューバー針を挿入することによって調節される。ヒューバー針が取り除かれると、隔膜は隔膜によって生み出される圧縮性の負荷によって穴（ヒューバー針が穿刺した穴）を密閉する。柔軟な導管が注入ポートと調節可能な胃バンドとの間で連通している。   In addition to a fastening position for setting the outer diameter of the gastric band, the gastric band is inflatable inwardly similar to a balloon blood pressure cuff where fluid, such as saline, is injected through the fluid infusion port to achieve the desired diameter. It is made adjustable by a balloon. Since adjustable balloons may be left in the patient's body for extended periods of time, fluid injection ports are typically implanted subcutaneously, eg, in front of the sternum, to prevent contamination. The amount of fluid in the adjustable gastric band is adjusted by inserting a Huber needle through the skin into the silicone of the injection port. When the Huber needle is removed, the diaphragm seals the hole (the hole pierced by the Huber needle) by the compressive load created by the diaphragm. A flexible conduit communicates between the injection port and the adjustable gastric band.

血管に用いるために開発された流体注入ポートを固定するための従来の外科的な方法は、周縁の基部フランジに沿って間隔を置いて配置された複数の穴を通して縫合を行うものであった。大まかに言って有効であるが、縫合は難しく時間を費やすものであることが多く、病的な肥満を治療するための調節可能な胃バンドを用いる場合にはなおさらそうである。厚い脂肪組織が皮膚の下に横たわっていることもあり、そのような場合には外科医が深く奥まった組織（例えば５ｃｍから１０ｃｍ）を縫合しようと試みると困難さが増し完了までに１０分から１５分を要することが多い。さらに、注入ポートが適切に縫合されていない場合には、注入ポートはひっくり返ることもあり、その後の注入を困難または不可能にする。   A conventional surgical method for securing a fluid injection port developed for use in a blood vessel has been to suture through a plurality of holes spaced along a peripheral base flange. While generally effective, suturing is often difficult and time consuming, especially when using adjustable gastric bands to treat morbid obesity. Thick adipose tissue may lie under the skin, in which case it will be more difficult if the surgeon attempts to suture deeply deep tissue (eg, 5-10 cm) and 10-15 minutes to complete Often required. In addition, if the injection port is not properly sutured, the injection port can be turned over, making subsequent injection difficult or impossible.

最近では、外科ステープラーが特許文献１（ピエール（Pier）による独国特許出願公開第１９７５１７９１．９号明細書）に記載されていて、この外科ステープラーではハット形の注入ポートが注入ポートの周縁に沿った間隔を置いて配置された接線に沿って並んだ直線状の溝を含んでいる。直線状の溝の一対の穴が伝統的な曲がったワイヤステープルを受容する。ステープラーはステープを所定の位置に保持し、各ステープルの肩部を押す下向に動く形成部材を有する。直線状の溝内の穴の位置によって、ステープルの先端は下側の組織をつかむように内向きに変形される。   Recently, a surgical stapler has been described in US Pat. No. 5,047,017 (German Patent Publication No. 19751791.9 by Pierre), in which a hat-shaped injection port runs along the periphery of the injection port. It includes straight grooves arranged along tangents that are spaced apart. A pair of holes in a straight groove accepts traditional bent wire staples. The stapler has a forming member that moves downwardly to hold the staple in place and push the shoulder of each staple. Depending on the position of the hole in the straight groove, the staple tip is deformed inward to grab the underlying tissue.

したがってこのピエールのステープラーは最初の配置が望ましくない場合または胃バンドを取り除くことが適切な場合に取り外すのが難しいことが判明している変形によってステープルを取り付ける。さらに、ステープラーは多数のステンレス鋼またはチタン製のステープルを半永久的に変形しなければならないので、より複雑な機構がステープルを容易に変形するのに十分な機械的拡大率を外科医に提供するために必要とされる。ピエールの注入ポートはその他の目的に対しては有用でない専用のステープラーハンドルをも必要とし、そのことがピエールの注入ポートを多数回配置しない外科医には好ましくない経費となることもある。   Thus, this Pierre stapler attaches staples by a deformation that has proven difficult to remove when initial placement is undesirable or when it is appropriate to remove the gastric band. In addition, the stapler must deform a large number of stainless steel or titanium staples semi-permanently, so that a more complex mechanism provides the surgeon with sufficient mechanical magnification to easily deform the staples. Needed. The Pierre injection port also requires a dedicated stapler handle that is not useful for other purposes, which may be undesirable for surgeons who do not deploy the Pierre injection port multiple times.

注入ポート用の専用のステープラーは取り付けを完了するのに要する時間など縫合に対する利点を有するかもしれないが、注入ポートを取り付けるための別の方法が従来の縫合または曲がったワイヤステープルを用いるステープラーでは提供されない別の利点または特徴を有するかもしれない。
独国特許出願公開第１９７５１７９１．９号明細書 While a dedicated stapler for the injection port may have advantages for suturing, such as the time it takes to complete the attachment, alternative methods for attaching the infusion port are provided with staples using conventional stitching or bent wire staples You may have another advantage or feature that is not done.
German Patent Application Publication No. 19751791.9

したがって、迅速に取り付けられながら長期間に亘って保持される皮下の取り付けに適した流体注入ポートがとても必要とされている。   Therefore, there is a great need for a fluid injection port suitable for subcutaneous attachment that can be quickly attached and held for an extended period of time.

本明細書に記載されているように、体内に流体を注入するための注入ポートが提供されている。その注入ポートは体の皮膚の下に配置するためのハウジングと針を受容するための手段とを含んでいる。ハウジングを取り囲む組織に係合してハウジングを定位置に維持するように構成された取り付け機構が設けられている。その取り付け機構はハウジングに一体的に取り付けられていてかつハウジングに対して固定されている。複数の締結具は、締結具が引き抜かれるのを防止しかつ注入ポートが意図せずに動くのを防止するための一方向性の締結具として働く切頭円錐形のフランジの形態の保持部材を含んでいる。   As described herein, an injection port for injecting fluid into the body is provided. The injection port includes a housing for placement under the body skin and means for receiving a needle. An attachment mechanism is provided that is configured to engage tissue surrounding the housing to maintain the housing in place. The attachment mechanism is integrally attached to the housing and fixed to the housing. The plurality of fasteners includes a retaining member in the form of a frustoconical flange that acts as a unidirectional fastener to prevent the fastener from being pulled out and to prevent unintentional movement of the injection port. Contains.

本明細書に組み込まれ本明細書の一部をなす添付の図面は本発明のいくつかの側面を例示し詳細な説明と共に本発明の原理を説明する働きをする。   The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several aspects of the invention and, together with the detailed description, serve to explain the principles of the invention.

本発明によれば、迅速に取り付けられながら長期間に亘って保持される流体注入ポートが提供される効果がある。   According to the present invention, there is an effect that a fluid injection port that can be quickly attached and held for a long period of time is provided.

本発明の現在の好ましい実施の形態がこれから詳細に説明され、好ましい実施の形態の例が添付の図面に示されている。   Reference will now be made in detail to presently preferred embodiments of the invention, examples of which are illustrated in the accompanying drawings.

類似の符号が全ての図面を通して類似した要素を示している図面を詳しく参照すると、図１には調節可能な胃バンド１０が胃１２の上部に巻き付けられた状態で示されていて、胃バンド１０は両端を一体に取り付け、調節可能な胃バンド１０に被さるように延びる胃１２の延長部分１４を胃１２に縫合することによって所定の位置に保持されている。柔軟な導管１６の一方の端部はバルーン（図示されていない。）の内部キャビティと流体連通していて、もう一方の端部は注入ポート１８の内部キャビティと流体連通している。調節可能な胃バンド１０が胃１２の一部の周りに植込まれるとき、離れて配置された注入ポート１８も適切な位置に、通常は腹直筋鞘内に植込まれて、ヒューバー針を用いて経皮的にアクセスできるようにされる。   Referring to the drawings in which like numerals indicate similar elements throughout the drawings, FIG. 1 shows an adjustable gastric band 10 wrapped around the upper portion of the stomach 12. Are held in place by stitching an extension 14 of the stomach 12 that extends over the adjustable gastric band 10 to the stomach 12 together. One end of the flexible conduit 16 is in fluid communication with the internal cavity of the balloon (not shown) and the other end is in fluid communication with the internal cavity of the injection port 18. When the adjustable gastric band 10 is implanted around a portion of the stomach 12, a remotely located injection port 18 is also implanted in place, usually within the rectus sheath, with the Huber needle Used to allow percutaneous access.

よく知られているように、注入ポート１８は一方の端部から外向きに延出している環状フランジ２２を備えたハウジング２０を含んでいる。ニップル２４がハウジング２０によって画定された内部キャビティ２６と流体連通していて、ニップル２４には手技のある時点で、典型的には注入ポート１８が植込まれた後に柔軟な導管１６が取り付けられる。流体が注入ポート１８のシリコーン製の隔膜２６に経皮的にヒューバー針を挿入することによって注入ポート１８の内部キャビティへ加えられまたは内部キャビティから取り除かれる。隔膜２６はシリコーンで作られているが、注入ポートの針を受容するための手段には、非孔あけ針（non-coring needle）が穿通した後に自動的に密閉するように構成された任意の構造などがある。   As is well known, the injection port 18 includes a housing 20 with an annular flange 22 extending outwardly from one end. A nipple 24 is in fluid communication with an internal cavity 26 defined by the housing 20, and at some point in the procedure, the flexible conduit 16 is typically attached after the injection port 18 has been implanted. Fluid is added to or removed from the internal cavity of the injection port 18 by percutaneously inserting a Huber needle into the silicone septum 26 of the injection port 18. Although the diaphragm 26 is made of silicone, means for receiving the needle of the injection port include any seal configured to automatically seal after a non-coring needle has penetrated. There are structures.

注入ポート１８の特定の構成が本明細書で開示されているが、本発明と共に用いることのできるさまざまな適切な構造がある。   Although specific configurations of the injection port 18 are disclosed herein, there are a variety of suitable structures that can be used with the present invention.

図２および図３をも参照すると、注入ポート１８はハウジング２０から遠位の向きに延出する一体的な締結具２８を含んでいる。締結具２８はハウジング２０のフランジ２２に形成された周方向に間隔を置いて配置された開口３０（図３が参照される。）を通して配置されている。本発明の教示内容は、基部を通って形成された開口を取り囲むハウジング２０の側面の凹部を形成することによって実施されるようなより小さなフランジによってまたはフランジなしで実施されてもよい。３個の締結具２８は注入ポート１８が患者の受動的な動きまたは誘導された動きになどによって植え込みの後にひっくり返るのを防止するのに有効である。しかし、本発明は３個の締結具を用いることに限定されず、ひとつまたはより多くの締結具が用いられてもよい。   Referring also to FIGS. 2 and 3, the injection port 18 includes an integral fastener 28 that extends distally from the housing 20. Fasteners 28 are disposed through circumferentially spaced openings 30 (see FIG. 3) formed in flange 22 of housing 20. The teachings of the present invention may be practiced with or without a smaller flange as is practiced by forming a recess in the side of housing 20 that surrounds an opening formed through the base. The three fasteners 28 are effective to prevent the infusion port 18 from tipping over after implantation, such as due to passive or guided movement of the patient. However, the present invention is not limited to using three fasteners, and one or more fasteners may be used.

図１から図３に示された一体的な締結具２８は一方向性の締結具である。本明細書では、一方向性の締結具は、筋膜またはその他の層に挿入されて係合し、筋膜またはその他の層から引き抜かれるのを防止するように構成された締結具を表している。外向きに延出し軸方向および周方向に間隔を置いて配置されたフィンガ部のような、そのような一方向性の機能を提供できるさまざまな異なる構造があるが、図示された締結具２８の実施の形態の一方向性の機能はシャフト部分３４に沿って軸方向に間隔を置いて配置された複数の切頭円錐形の環状のフランジ３２によってもたらされている。傾斜面を備えて図示された先端３６がシャフト部分３４の遠位の端部に形成されていて、ヘッド部３８がシャフト部分３４のもう一方の端部に配置されている。先端３６は任意の形状でよいが、筋膜またはその他の層の穿通を容易にする形状が注入ポート１８の配備／植え込みに必要な力を減らすことが分かる。   The integral fastener 28 shown in FIGS. 1-3 is a unidirectional fastener. As used herein, a unidirectional fastener represents a fastener configured to be inserted into and engaged with a fascia or other layer to prevent withdrawal from the fascia or other layer. Yes. There are a variety of different structures that can provide such unidirectional functions, such as outwardly extending axially and circumferentially spaced fingers, but the fastener 28 illustrated in FIG. The unidirectional function of the embodiment is provided by a plurality of frustoconical annular flanges 32 spaced axially along the shaft portion 34. A tip 36, shown with an inclined surface, is formed at the distal end of the shaft portion 34, and a head portion 38 is disposed at the other end of the shaft portion 34. The tip 36 may be any shape, but it will be appreciated that shapes that facilitate penetration of fascia or other layers reduce the force required to deploy / implant the infusion port 18.

フランジ３２は代わりに組織の性質によって引き抜かれることを防止する平坦な間隔を置いて配置されたフランジであってもよいが、平坦なフランジは切頭円錐形の後方に向けて傾斜した傾斜面を備えたフランジに比べて挿入時により大きな抵抗をもたらす。   The flange 32 may alternatively be a flat spaced flange that prevents it from being pulled out due to the nature of the tissue, but the flat flange has an inclined surface inclined toward the rear of the truncated cone. It provides greater resistance when inserted compared to the provided flange.

図示された実施の形態では、ヘッド部３８は開口３０よりも大きく、したがって開口３０を通過しないように構成されている。注入ポート１８を配備／植え込みする前に、締結具２８は締結具２８を開口３０を通して挿入することによってハウジング２０に一体的に取り付けられている。フランジ３２は開口３０を通るときに内向きに曲がるよう十分に変形可能であってよい。さらにフランジ３２はシャフト３４の長さ方向に沿った溝を有するなど各々のフランジの周方向で不連続であってもよい。フランジ３２ａは締結具２８を開口３０内でハウジング２０に接着させてかつハウジング２０に対して固定させて保持し、フランジ３２ａは開口３０を押されて通過した後に広がって開口３０に隣接したフランジ２２の下側面２２ａに係合してそれによって配備の前に注入ポート１８と締結具２８が一体的になるのに十分な間隔だけヘッド部３８の下側面３８ａから離れている。開口３０およびシャフト部分３４の間の半径方向の隙間または下側面３８ａおよびフランジ３２ａの間の軸方向の隙間があってもよい。   In the illustrated embodiment, the head portion 38 is larger than the opening 30 and is thus configured not to pass through the opening 30. Prior to deploying / implanting the injection port 18, the fastener 28 is integrally attached to the housing 20 by inserting the fastener 28 through the opening 30. The flange 32 may be sufficiently deformable to bend inward as it passes through the opening 30. Further, the flange 32 may be discontinuous in the circumferential direction of each flange, such as having a groove along the length direction of the shaft 34. The flange 32 a holds the fastener 28 bonded to the housing 20 in the opening 30 and is fixed to the housing 20, and the flange 32 a expands after being pushed through the opening 30 and is adjacent to the opening 30. Is spaced from the lower side 38a of the head portion 38 by a sufficient distance to engage the lower side 22a and thereby integrate the injection port 18 and fastener 28 together prior to deployment. There may be a radial gap between the opening 30 and the shaft portion 34 or an axial gap between the lower side 38a and the flange 32a.

締結具２８は配備の前にまたは配備するときに任意の時点で注入ポート１８に取り付けられてよいが、注入ポート１８が滅菌されたアセンブリとして予め取り付けられた一体的な締結具２８として外科医に提供されることも考えられている。   The fastener 28 may be attached to the injection port 18 before or at the time of deployment, but is provided to the surgeon as an integral fastener 28 with the injection port 18 pre-attached as a sterilized assembly. It is also considered to be done.

自動取り付け式注入ポート１８は注入ポート１８を所望の位置に配置し注入ポート１８のハウジング２０またはちょうどヘッド部３８に遠位の向きの力を加えることによって締結具２８の先端３６を隣接する組織に係合させて図示されているように脂肪層４０および筋膜層４２を穿通することによって植え込まれる。切頭円錐形のフランジ３２がヘッド部３８に対して平行に角度をなしていることによって、締結具２８は脂肪層４０および筋膜層４２を穿通して前進すると共に引き抜かれることを防止するように脂肪層４０および筋膜層４２に対して固定される。同中心で軸方向に間隔を置いて配置された固定リングとして動作して、フランジ３２は注入ポート１８を定位置に維持する。   The self-attaching injection port 18 places the tip 36 of the fastener 28 on adjacent tissue by placing the injection port 18 in the desired location and applying a distally directed force to the housing 20 or just the head 38 of the injection port 18. Implanted by penetrating through the fat layer 40 and fascial layer 42 as shown. The frustoconical flange 32 is angled parallel to the head portion 38 so that the fastener 28 advances through the fat layer 40 and fascial layer 42 and prevents it from being pulled out. It is fixed to the fat layer 40 and the fascial layer 42. Acting as a concentric, axially spaced fixation ring, the flange 32 maintains the injection port 18 in place.

締結具２８は、ポリカーボネート、ポリスチレン、または任意の適切なポリマーなど本明細書に記載されたように実施される十分な弾性および強度を備えた任意の適切な医学的な適合性を有する材料で作られてよい。フランジ３２の個数、間隔、および寸法は適切な任意の個数、間隔、および寸法であってよい。単に例示の目的で、シャフトが５ｍｍの長さの場合、フランジ３２の中心間の距離は３ｍｍであり、（シャフト部分での）厚みは１ｍｍであり、直径は３ｍｍである。   Fastener 28 is made of any suitable medically compatible material with sufficient elasticity and strength to be implemented as described herein, such as polycarbonate, polystyrene, or any suitable polymer. May be. The number, spacing, and dimensions of the flanges 32 may be any suitable number, spacing, and dimensions. For exemplary purposes only, if the shaft is 5 mm long, the distance between the centers of the flanges 32 is 3 mm, the thickness (at the shaft portion) is 1 mm, and the diameter is 3 mm.

要約すると、本発明の発想を用いることによって得られるさまざまな利点が記載された。本発明のひとつまたは複数の実施の形態のこれまでの記載は、例示および説明のために提供された。これまでの記載は網羅的なものであることも本発明を開示された形態そのままに限定することも意図されていない。明らかな変形および変更は上記の教示内容の様相の範囲内で可能である。例えば、ひとつまたは複数の切頭円錐形のフランジを備えたひとつまたは複数の締結具が、注入ポートを体の適正な位置に配置して次に締結具を開口を通して挿入するなどして、植え込み時に注入ポートの適正な形の開口を通して挿入されてもよい。   In summary, the various advantages obtained by using the inventive idea have been described. The foregoing description of one or more embodiments of the invention has been provided for the purposes of illustration and description. The above description is not intended to be exhaustive or to limit the invention to the precise form disclosed. Obvious variations and modifications are possible within the scope of the teachings described above. For example, one or more fasteners with one or more frustoconical flanges may be placed at the time of implantation, such as placing the injection port in the proper position on the body and then inserting the fasteners through the openings. It may be inserted through a properly shaped opening in the injection port.

ひとつまたは複数の実施の形態が本発明の原理および実際の用途を最良に例示して当業者が企図される個々の用途に適するように本発明をさまざまな実施の形態でかつさまざまに変更して最良に用いることができるようにするために選択されて記載された。   The invention may be modified in various embodiments and in various modifications so that one or more embodiments best illustrate the principles and practical applications of the invention and are suitable for individual applications contemplated by those skilled in the art. Selected and described for best use.

この発明の具体的な実施態様は以下の通りである。
（１）体内に流体を注入するための注入ポートであって、
（ａ）体の皮膚の下に配置するための、針を受容する手段を含むハウジングと、
（ｂ）上記ハウジングを定位置に保持するように上記ハウジングを取り囲む組織に係合するよう構成されていて、上記ハウジングに一体的に取り付けられていると共に上記ハウジングに対して固定されている取り付け機構と
を有する、体内に流体を注入するための注入ポート。
（２）取り付け機構が、ハウジングに遠位の向きの力を加えることによって上記取り付け機構が組織に係合して上記ハウジングを維持するように構成されている、上記実施態様（１）記載の注入ポート。
（３）取り付け機構がハウジングから遠位の向きに延出する少なくともひとつの締結具を含む、上記実施態様（１）記載の注入ポート。
（４）少なくともひとつの締結具が組織を穿通するように構成された対応する遠位の先端を有する、上記実施態様（３）記載の注入ポート。
（５）少なくともひとつの締結具がハウジングから離れて配置された少なくともひとつの外向きに延出するフランジを有する、上記実施態様（３）記載の注入ポート。 Specific embodiments of the present invention are as follows.
(1) An injection port for injecting fluid into the body,
(A) a housing including means for receiving a needle for placement under the skin of the body;
(B) an attachment mechanism configured to engage with tissue surrounding the housing to hold the housing in place, and is integrally attached to the housing and fixed to the housing; An injection port for injecting fluid into the body.
(2) The injection according to embodiment (1), wherein the attachment mechanism is configured to engage the tissue to maintain the housing by applying a distally directed force to the housing. port.
(3) The injection port of embodiment (1), wherein the attachment mechanism includes at least one fastener extending distally from the housing.
(4) The injection port of embodiment (3), wherein the at least one fastener has a corresponding distal tip configured to penetrate tissue.
(5) The injection port according to embodiment (3), wherein the at least one fastener has at least one outwardly extending flange disposed away from the housing.

（６）少なくともひとつのフランジが、間隔を置いて配置された複数のフランジからなる、上記実施態様（５）記載の注入ポート。
（７）少なくともひとつのフランジが切頭円錐形の形状を有する、上記実施態様（５）記載の注入ポート。
（８）少なくともひとつのフランジが不連続である、上記実施態様（３）記載の注入ポート。
（９）少なくともひとつの締結具がハウジングから離れて配置された少なくともひとつの外向きに延出するフィンガ部を有する、上記実施態様（３）記載の注入ポート。
（１０）少なくともひとつのフィンガ部が間隔を置いて配置された複数のフィンガ部からなる、上記実施態様（９）記載の注入ポート。 (6) The injection port according to the embodiment (5), wherein the at least one flange includes a plurality of flanges arranged at intervals.
(7) The injection port according to the embodiment (5), wherein at least one flange has a truncated conical shape.
(8) The injection port according to the embodiment (3), wherein at least one flange is discontinuous.
(9) The injection port according to embodiment (3), wherein the at least one fastener has at least one outwardly extending finger portion disposed away from the housing.
(10) The injection port according to the embodiment (9), wherein the at least one finger part is composed of a plurality of finger parts arranged at intervals.

（１１）少なくともひとつの締結具の各々に対応する開口をさらに有し、上記少なくともひとつの締結具が上記開口を通して配置される、上記実施態様（３）記載の注入ポート。
（１２）ハウジングが、上記ハウジングの一方の端部付近に延在する環状フランジを含み、対応する開口が上記環状フランジに形成されている、上記実施態様（１１）記載の注入ポート。
（１３）体内に流体を注入するための注入ポートを配備する方法であって、
（ａ）（ｉ）体の皮膚の下に配置するための、針を受容する手段を含むハウジングと、（ｉｉ）上記ハウジングを定位置に保持するように上記ハウジングを取り囲む組織に係合するように構成されていて、上記ハウジングに一体的に取り付けられていると共に上記ハウジングに対して固定されている取り付け機構とを有する、注入ポートを提供する過程と、
（ｂ）上記取り付け機構を上記組織に隣接して配置する過程と、
（ｃ）上記ハウジングに遠位の向きに力を加えて上記取り付け機構で上記組織を穿通する過程と
を有する、体内に流体を注入するための注入ポートを配備する方法。
（１４）取り付け機構がハウジングから遠位の向きに延在する少なくともひとつの締結具を含む、上記実施態様（１３）記載の方法。
（１５）少なくともひとつの締結具が、組織を穿通するように構成された対応する先端を有する、上記実施態様（１４）記載の方法。 (11) The injection port according to embodiment (3), further comprising an opening corresponding to each of the at least one fastener, wherein the at least one fastener is disposed through the opening.
(12) The injection port according to the embodiment (11), wherein the housing includes an annular flange extending near one end of the housing, and a corresponding opening is formed in the annular flange.
(13) A method of deploying an injection port for injecting fluid into the body,
(A) (i) a housing including means for receiving a needle for placement under the skin of the body; and (ii) engaging tissue surrounding the housing to hold the housing in place. Providing an injection port having an attachment mechanism that is integrally attached to the housing and secured to the housing; and
(B) placing the attachment mechanism adjacent to the tissue;
(C) A method of deploying an injection port for injecting fluid into the body, comprising applying a force distally to the housing and penetrating the tissue with the attachment mechanism.
(14) The method of embodiment (13), wherein the attachment mechanism includes at least one fastener extending distally from the housing.
(15) The method of embodiment (14), wherein the at least one fastener has a corresponding tip configured to penetrate tissue.

（１６）少なくともひとつの締結具が、ハウジングから離れて配置された外向きに延出する少なくともひとつのフランジを有する、上記実施態様（１４）記載の方法。
（１７）少なくともひとつのフランジが、間隔を置いて配置された複数のフランジからなる、上記実施態様（１６）記載の方法。
（１８）少なくともひとつのフランジが切頭円錐形の形状を有する、上記実施態様（１６）記載の方法。
（１９）少なくともひとつの締結具がハウジングから離れて配置された外向きに延出する少なくともひとつのフィンガ部を有する、上記実施態様（１４）記載の方法。
（２０）ハウジングが、上記ハウジングの一方の端部付近に延在する環状フランジを含み、上記環状フランジが少なくともひとつの締結具の各々に対応する開口を有し、上記少なくともひとつの締結具の各々が上記開口を通して配置される、上記実施態様（１４）記載の方法。 (16) The method of embodiment (14), wherein the at least one fastener has at least one outwardly extending flange disposed away from the housing.
(17) The method according to the above embodiment (16), wherein the at least one flange includes a plurality of flanges arranged at intervals.
(18) The method according to embodiment (16), wherein at least one flange has a frustoconical shape.
(19) The method of embodiment (14), wherein the at least one fastener has at least one outwardly extending finger portion disposed away from the housing.
(20) The housing includes an annular flange extending near one end of the housing, the annular flange having an opening corresponding to each of the at least one fastener, and each of the at least one fastener. The method of embodiment (14), wherein is disposed through the opening.

（２１）体内に流体を注入するための注入ポートを配備する方法であって、
（ａ）（ｉ）体の皮膚の下に配置するための、針を受容する手段を含むハウジングを有する注入ポートであって、（ｉｉ）上記ハウジングが第１の表面および第２の表面を備えた基部を有し、上記基部が上記第１の表面から上記第２の表面まで上記基部を貫通する少なくともひとつの開口を含む、上記注入ポートを提供する過程と、
（ｂ）（ｉ）第１の端部および第２の端部を備えたシャフトと、（ｉｉ）上記シャフトから外向きに延出し上記第１の端部から離れて配置された少なくともひとつのフランジとを有する少なくともひとつの締結具を提供する過程と、
（ｃ）上記第２の表面を体の組織に隣接して配置する過程と、
（ｄ）上記第２の表面に隣接して配置された上記組織を上記少なくともひとつのフランジと係合させるように上記少なくともひとつの締結具を上記少なくともひとつの開口を通して挿入することによって上記注入ポートを上記組織に隣接して取り付ける過程と
を有する、体内に流体を注入するための注入ポートを配備する方法。
（２２）少なくともひとつのフランジが、シャフトの軸方向に沿って互いに間隔を置いて配置された複数のフランジからなる、上記実施態様（２１）記載の方法。
（２３）複数のフランジが切頭円錐形の環状フランジからなる、上記実施態様（２２）記載の方法。
（２４）少なくともひとつのフランジが切頭円錐形の形状を有する、上記実施態様（２１）記載の方法。 (21) A method of deploying an injection port for injecting a fluid into a body,
(A) (i) an injection port having a housing including means for receiving a needle for placement under the skin of the body, (ii) said housing comprising a first surface and a second surface Providing the injection port with a base, the base including at least one opening through the base from the first surface to the second surface;
(B) (i) a shaft having a first end and a second end; and (ii) at least one flange extending outwardly from the shaft and spaced apart from the first end. Providing at least one fastener having:
(C) placing the second surface adjacent to body tissue;
(D) inserting the at least one fastener through the at least one opening to engage the tissue disposed adjacent to the second surface with the at least one flange; A method of deploying an injection port for injecting fluid into the body, the method comprising attaching adjacent to the tissue.
(22) The method according to the above embodiment (21), wherein the at least one flange includes a plurality of flanges spaced apart from each other along the axial direction of the shaft.
(23) The method according to the above-mentioned embodiment (22), wherein the plurality of flanges are frustoconical annular flanges.
(24) The method according to embodiment (21), wherein at least one flange has a truncated cone shape.

胃の上部に巻き付けられた調節可能な胃バンドに結合された本発明に基づいて構成された注入ポートを示す模式図である。FIG. 3 is a schematic diagram showing an injection port constructed in accordance with the present invention coupled to an adjustable gastric band wrapped around the upper portion of the stomach. 図１に示された注入ポートの斜視図である。FIG. 2 is a perspective view of an injection port shown in FIG. 1. 図１に示された注入ポートの一部の拡大側面図である。FIG. 2 is an enlarged side view of a part of the injection port shown in FIG. 1.

符号の説明Explanation of symbols

１０ 胃バンド
１２ 胃
１４ 延長部分
１６ 導管
１８ 注入ポート
２０ ハウジング
２２ 環状フランジ
２２ａ 下側面
２４ ニップル
２６ 隔膜
２８ 締結具
３０ 開口
３２ フランジ
３２ａ フランジ
３４ シャフト部分
３６ 先端
３８ ヘッド部
３８ａ 下側面
４０ 脂肪層
４２ 筋膜層
DESCRIPTION OF SYMBOLS 10 Gastric band 12 Stomach 14 Extension part 16 Conduit 18 Injection | pouring port 20 Housing 22 Annular flange 22a Lower side 24 Nipple 26 Diaphragm 28 Fastener 30 Opening 32 Flange 32a Flange 34 Shaft part 36 Tip 38 Head part 38a Lower side 40 Fat layer 42 Muscle Membrane layer

Claims (12)

体内に流体を注入するための注入ポートであって、
（ａ）体の皮膚の下に配置するための、針を受容する手段を含むハウジングと、
（ｂ）上記ハウジングを定位置に保持するように上記ハウジングを取り囲む組織に係合するよう構成されていて、上記ハウジングに一体的に取り付けられていると共に上記ハウジングに対して固定されている取り付け機構と
を有する、体内に流体を注入するための注入ポート。 An injection port for injecting fluid into the body,
(A) a housing including means for receiving a needle for placement under the skin of the body;
(B) an attachment mechanism configured to engage with tissue surrounding the housing to hold the housing in place, and is integrally attached to the housing and fixed to the housing; An injection port for injecting fluid into the body. 取り付け機構が、ハウジングに遠位の向きの力を加えることによって上記取り付け機構が組織に係合して上記ハウジングを維持するように構成されている、請求項１記載の注入ポート。   The injection port of claim 1, wherein the attachment mechanism is configured to engage the tissue to maintain the housing by applying a distally directed force to the housing. 取り付け機構がハウジングから遠位の向きに延出する少なくともひとつの締結具を含む、請求項１記載の注入ポート。   The infusion port of claim 1, wherein the attachment mechanism includes at least one fastener extending distally from the housing. 少なくともひとつの締結具が組織を穿通するように構成された対応する遠位の先端を有する、請求項３記載の注入ポート。   The infusion port of claim 3, wherein the at least one fastener has a corresponding distal tip configured to penetrate tissue. 少なくともひとつの締結具がハウジングから離れて配置された少なくともひとつの外向きに延出するフランジを有する、請求項３記載の注入ポート。   The injection port of claim 3, wherein the at least one fastener has at least one outwardly extending flange disposed remotely from the housing. 少なくともひとつのフランジが、間隔を置いて配置された複数のフランジからなる、請求項５記載の注入ポート。   The injection port of claim 5, wherein the at least one flange comprises a plurality of spaced flanges. 少なくともひとつのフランジが切頭円錐形の形状を有する、請求項５記載の注入ポート。   The injection port of claim 5, wherein the at least one flange has a frustoconical shape. 少なくともひとつのフランジが不連続である、請求項３記載の注入ポート。   4. The injection port of claim 3, wherein at least one flange is discontinuous. 少なくともひとつの締結具がハウジングから離れて配置された少なくともひとつの外向きに延出するフィンガ部を有する、請求項３記載の注入ポート。   4. The injection port of claim 3, wherein the at least one fastener has at least one outwardly extending finger portion disposed away from the housing. 少なくともひとつのフィンガ部が間隔を置いて配置された複数のフィンガ部からなる、請求項９記載の注入ポート。   The injection port of claim 9, wherein the at least one finger portion comprises a plurality of spaced apart finger portions. 体内に流体を注入するための注入ポートを配備する方法であって、
（ａ）（ｉ）体の皮膚の下に配置するための、針を受容する手段を含むハウジングと、（ｉｉ）上記ハウジングを定位置に保持するように上記ハウジングを取り囲む組織に係合するように構成されていて、上記ハウジングに一体的に取り付けられていると共に上記ハウジングに対して固定されている取り付け機構とを有する、注入ポートを提供する過程と、
（ｂ）上記取り付け機構を上記組織に隣接して配置する過程と、
（ｃ）上記ハウジングに遠位の向きに力を加えて上記取り付け機構で上記組織を穿通する過程と
を有する、体内に流体を注入するための注入ポートを配備する方法。 A method of deploying an injection port for injecting fluid into the body,
(A) (i) a housing including means for receiving a needle for placement under the skin of the body; and (ii) engaging tissue surrounding the housing to hold the housing in place. Providing an injection port having an attachment mechanism that is integrally attached to the housing and secured to the housing; and
(B) placing the attachment mechanism adjacent to the tissue;
(C) A method of deploying an injection port for injecting fluid into the body, comprising applying a force distally to the housing and penetrating the tissue with the attachment mechanism. 体内に流体を注入するための注入ポートを配備する方法であって、
（ａ）（ｉ）体の皮膚の下に配置するための、針を受容する手段を含むハウジングを有する注入ポートであって、（ｉｉ）上記ハウジングが第１の表面および第２の表面を備えた基部を有し、上記基部が上記第１の表面から上記第２の表面まで上記基部を貫通する少なくともひとつの開口を含む、上記注入ポートを提供する過程と、
（ｂ）（ｉ）第１の端部および第２の端部を備えたシャフトと、（ｉｉ）上記シャフトから外向きに延出し上記第１の端部から離れて配置された少なくともひとつのフランジとを有する少なくともひとつの締結具を提供する過程と、
（ｃ）上記第２の表面を体の組織に隣接して配置する過程と、
（ｄ）上記第２の表面に隣接して配置された上記組織を上記少なくともひとつのフランジと係合させるように上記少なくともひとつの締結具を上記少なくともひとつの開口を通して挿入することによって上記注入ポートを上記組織に隣接して取り付ける過程と
を有する、体内に流体を注入するための注入ポートを配備する方法。
A method of deploying an injection port for injecting fluid into the body,
(A) (i) an injection port having a housing including means for receiving a needle for placement under the skin of the body, (ii) said housing comprising a first surface and a second surface Providing the injection port with a base, the base including at least one opening through the base from the first surface to the second surface;
(B) (i) a shaft having a first end and a second end; and (ii) at least one flange extending outwardly from the shaft and spaced apart from the first end. Providing at least one fastener having:
(C) placing the second surface adjacent to body tissue;
(D) inserting the at least one fastener through the at least one opening to engage the tissue disposed adjacent to the second surface with the at least one flange; A method of deploying an injection port for injecting fluid into the body, the method comprising attaching adjacent to the tissue.
JP2004366378A 2003-12-19 2004-12-17 Infusion port for injecting fluid into the body and method for deploying an infusion port Expired - Fee Related JP4828119B2 (en)

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CN1644172A (en) 2005-07-27
US20040254536A1 (en) 2004-12-16
EP1547643A1 (en) 2005-06-29
DE602004021550D1 (en) 2009-07-30
US7374557B2 (en) 2008-05-20
BRPI0405617A (en) 2006-04-04
AU2004235666A1 (en) 2005-07-07
JP4828119B2 (en) 2011-11-30
CN100558300C (en) 2009-11-11
CA2490171A1 (en) 2005-06-19
EP1547643B1 (en) 2009-06-17
ATE433777T1 (en) 2009-07-15
CA2490171C (en) 2012-12-11

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